Core Outcome Set-STAndards for Development: The COS-STAD recommendations.

<h4>Background</h4>The use of core outcome sets (COS) ensures that researchers measure and report those outcomes that are most likely to be relevant to users of their research. Several hundred COS projects have been systematically identified to date, but there has been no formal quality...

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Main Authors: Jamie J Kirkham, Katherine Davis, Douglas G Altman, Jane M Blazeby, Mike Clarke, Sean Tunis, Paula R Williamson
Format: Article
Language:English
Published: Public Library of Science (PLoS) 2017-11-01
Series:PLoS Medicine
Online Access:https://doi.org/10.1371/journal.pmed.1002447
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author Jamie J Kirkham
Katherine Davis
Katherine Davis
Douglas G Altman
Jane M Blazeby
Mike Clarke
Sean Tunis
Paula R Williamson
author_facet Jamie J Kirkham
Katherine Davis
Katherine Davis
Douglas G Altman
Jane M Blazeby
Mike Clarke
Sean Tunis
Paula R Williamson
author_sort Jamie J Kirkham
collection DOAJ
description <h4>Background</h4>The use of core outcome sets (COS) ensures that researchers measure and report those outcomes that are most likely to be relevant to users of their research. Several hundred COS projects have been systematically identified to date, but there has been no formal quality assessment of these studies. The Core Outcome Set-STAndards for Development (COS-STAD) project aimed to identify minimum standards for the design of a COS study agreed upon by an international group, while other specific guidance exists for the final reporting of COS development studies (Core Outcome Set-STAndards for Reporting [COS-STAR]).<h4>Methods and findings</h4>An international group of experienced COS developers, methodologists, journal editors, potential users of COS (clinical trialists, systematic reviewers, and clinical guideline developers), and patient representatives produced the COS-STAD recommendations to help improve the quality of COS development and support the assessment of whether a COS had been developed using a reasonable approach. An open survey of experts generated an initial list of items, which was refined by a 2-round Delphi survey involving nearly 250 participants representing key stakeholder groups. Participants assigned importance ratings for each item using a 1-9 scale. Consensus that an item should be included in the set of minimum standards was defined as at least 70% of the voting participants from each stakeholder group providing a score between 7 and 9. The Delphi survey was followed by a consensus discussion with the study management group representing multiple stakeholder groups. COS-STAD contains 11 minimum standards that are the minimum design recommendations for all COS development projects. The recommendations focus on 3 key domains: the scope, the stakeholders, and the consensus process.<h4>Conclusions</h4>The COS-STAD project has established 11 minimum standards to be followed by COS developers when planning their projects and by users when deciding whether a COS has been developed using reasonable methods.
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spelling doaj-art-12c362ac4ea146a59563bafe95079d192025-08-20T02:23:15ZengPublic Library of Science (PLoS)PLoS Medicine1549-12771549-16762017-11-011411e100244710.1371/journal.pmed.1002447Core Outcome Set-STAndards for Development: The COS-STAD recommendations.Jamie J KirkhamKatherine DavisKatherine DavisDouglas G AltmanJane M BlazebyMike ClarkeSean TunisPaula R Williamson<h4>Background</h4>The use of core outcome sets (COS) ensures that researchers measure and report those outcomes that are most likely to be relevant to users of their research. Several hundred COS projects have been systematically identified to date, but there has been no formal quality assessment of these studies. The Core Outcome Set-STAndards for Development (COS-STAD) project aimed to identify minimum standards for the design of a COS study agreed upon by an international group, while other specific guidance exists for the final reporting of COS development studies (Core Outcome Set-STAndards for Reporting [COS-STAR]).<h4>Methods and findings</h4>An international group of experienced COS developers, methodologists, journal editors, potential users of COS (clinical trialists, systematic reviewers, and clinical guideline developers), and patient representatives produced the COS-STAD recommendations to help improve the quality of COS development and support the assessment of whether a COS had been developed using a reasonable approach. An open survey of experts generated an initial list of items, which was refined by a 2-round Delphi survey involving nearly 250 participants representing key stakeholder groups. Participants assigned importance ratings for each item using a 1-9 scale. Consensus that an item should be included in the set of minimum standards was defined as at least 70% of the voting participants from each stakeholder group providing a score between 7 and 9. The Delphi survey was followed by a consensus discussion with the study management group representing multiple stakeholder groups. COS-STAD contains 11 minimum standards that are the minimum design recommendations for all COS development projects. The recommendations focus on 3 key domains: the scope, the stakeholders, and the consensus process.<h4>Conclusions</h4>The COS-STAD project has established 11 minimum standards to be followed by COS developers when planning their projects and by users when deciding whether a COS has been developed using reasonable methods.https://doi.org/10.1371/journal.pmed.1002447
spellingShingle Jamie J Kirkham
Katherine Davis
Katherine Davis
Douglas G Altman
Jane M Blazeby
Mike Clarke
Sean Tunis
Paula R Williamson
Core Outcome Set-STAndards for Development: The COS-STAD recommendations.
PLoS Medicine
title Core Outcome Set-STAndards for Development: The COS-STAD recommendations.
title_full Core Outcome Set-STAndards for Development: The COS-STAD recommendations.
title_fullStr Core Outcome Set-STAndards for Development: The COS-STAD recommendations.
title_full_unstemmed Core Outcome Set-STAndards for Development: The COS-STAD recommendations.
title_short Core Outcome Set-STAndards for Development: The COS-STAD recommendations.
title_sort core outcome set standards for development the cos stad recommendations
url https://doi.org/10.1371/journal.pmed.1002447
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